Examining how sex differences affect heart fat and function
Mechanism and Modulation of Sex Differences in Myocardial Steatosis Induced Left Ventricular Dysfunction
This study is testing how heart fat and function differ between healthy men and premenopausal women to better understand how sex affects heart health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 30 Years |
| Sex | All |
| Sponsor | The University of Texas at Arlington Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Arlington, Texas) |
| Trial ID | NCT04671966 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of myocardial steatosis on left ventricular dysfunction, focusing on sex differences between healthy men and premenopausal women. Participants will undergo cardiac MRI and spectroscopy to assess heart structure and fat metabolism after a two-day fasting period to increase myocardial triglyceride content. The study will also evaluate metabolic health and hormonal levels through blood samples. The goal is to better understand how biological sex influences heart health and fat deposition.
Who should consider this trial
Good fit: Ideal candidates are healthy men and premenopausal women aged 18-50 with specific blood pressure and BMI criteria.
Not a fit: Patients with a history of estrogen-dependent neoplasms, cardiovascular disease, or those on hormone therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment strategies for heart diseases that consider sex differences.
How similar studies have performed: While there is ongoing research into sex differences in cardiovascular health, this specific approach focusing on myocardial steatosis and fasting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * blood pressure \<140/90 mmHg * BMI between 18.5 and 30 kg/m2 * sedentary or recreationally active (\<3 days of vigorous aerobic exercise each week) * no use of oral contraceptives hormone therapy, or other medications that might influence cardiovascular function * nonsmokers. Exclusion Criteria: * Women will be excluded with 1. history of or active estrogen-dependent neoplasms, acute liver or gallbladder disease, vaginal bleeding, venous thromboembolism, hypertriglyceridemia, and CVD 2. known allergy to transdermal patch, GnRHant (i.e., hypersensitivity to cetrorelix, extrinsic peptide hormones, mannitol, GnRH, benzyl alcohol - the vehicle for injection of cetrorelix) 3. history of stomach ulcer or bleeding 4. other contraindications to hormone replacement therapy or GnRHant, (i.e., taking Levodopa, medications that can inhibit folate metabolism including methotrexate). Other conditions for which individuals will be excluded from the study include: diabetes active infection history of seizures or disease that affects the nervous system sepsis an abnormal resting ECG contraindications to MRI pregnant or planning to become pregnant smoking history illicit drug use (excluding occasional marijuana).
Where this trial is running
Arlington, Texas
- University of Texas at Arlington — Arlington, Texas, United States (Recruiting)
Study contacts
- Principal investigator: michael nelson, PhD — University of Texas at Arlington
- Study coordinator: manall jaffery, MS
- Email: manalljaffery@gmail.com
- Phone: 14694264030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.